Phase 2
N=54
Citalopram in Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00477165 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Count of Participants Who Self-reported "Adequate Relief" — 12; 15 Participants — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Citalopram (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants Who Self-reported "Adequate Relief" |
12; 15 | 0.59 |
| SECONDARY Change From Baseline in IBS-QOL Score at Week 8 |
6.3; 7.6 | — |
| SECONDARY Mean Sensation Score as a Function of Distending Pressure at the End of the Study |
1; 2; 4; 6; 5; 7 | — |
| SECONDARY Urgency Score as a Function of Distending Pressure at the End of the Study |
1; 2; 4; 5; 4; 5 | — |
Summary
Hypotheses:
1. Primary null hypothesis: The rate of clinical response, assessed as patient-reported global symptom rating and "adequate relief of IBS symptoms," does not differ between non-depressed IBS patients treated with the SSRI citalopram and patients treated with placebo.
2. Secondary null hypotheses:
1. Changes in disease-related quality of life, assessed with the IBS-QOL instrument, do not differ between patients treated with the SSRI citalopram and patients treated with placebo.
2. Changes in rectosigmoid visceral sensitivity, assessed by barostat balloon distention, do not differ between patients treated with the SSRI citalopram and patients treated with placebo.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria are:
- Fulfilling Rome II IBS definition;
- Age ≥18 yrs and able to give informed consent;
- Normal sigmoidoscopy, colonoscopy or barium enema within 5 years, normal complete blood count and thyroid studies, and negative stool ova and parasite exam for patients with diarrhea.
Exclusion Criteria
Exclusion criteria are:
- Current psychiatric diagnosis or active treatment with antidepressants;
- Pregnancy;
- Major systemic illness, or illness that could explain IBS-like symptoms;
- Active IBS therapy other than fiber or loperamide.
Data sourced from ClinicalTrials.gov (NCT00477165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.